Atrial FibrillationrelievEDNCT06283654
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
An observational study of Atrial Fibrillation, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
In this study, the researchers explored a new approach to manage atrial fibrillation, a disease that affects millions worldwide. The goal was to see if using a simple handheld ECG device for monitoring heart rhythm could help patients avoid unnecessary visits to the emergency department (ED) after undergoing a common… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- 1-lead ECG
- Type of treatment
- Medical device
- How many people
- 204 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Sep 2018to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with all kinds of AF who underwent a PVI
Who may be able to join
- AF and PVI
Who cannot join
- <18y
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation: a Historically Controlled Prospective Trial
In this study, the researchers explored a new approach to manage atrial fibrillation, a disease that affects millions worldwide. The goal was to see if using a simple handheld ECG device for monitoring heart rhythm could help patients avoid unnecessary visits to the emergency department (ED) after undergoing a common procedure known as pulmonary vein isolation (PVI). This procedure is often used to treat AF, but following it patients frequently visit the ED due to concerns about their heart rhythm, which can strain healthcare resources. The researchers proved a group of patients with a 1-lead ECG device , which allowed users to check their heart rhythm at any time. The researchers compared the ED utilization over a year with that of patients who received standard care after PVI. The hope was that by using the 1-lead ECG device, patients could better manage their condition from home and only seek medical help when truly necessary.
Read the detailed description
Atrial fibrillation (AF) is a prevalent and clinically significant cardiac arrhythmia, with a growing incidence. The primary objectives in AF management are symptom relief, stroke risk reduction, and prevention of tachycardia-induced cardiomyopathy. Two key strategies for rhythm control include antiarrhythmic drug therapy and pulmonary vein isolation (PVI), with PVI being recommended for selected patients. Even though PVI is effective, post procedural health care utilization is high, contributing to emergency department (ED) overcrowding, which is a global healthcare concern. The use of remote rhythm diagnostics, such as a 1-lead ECG device, may mitigate this issue by reducing ED visits and facilitating more plannable AF care. Objective: This study aimed to assess whether providing AF patients with a 1-lead ECG device for 1 year after PVI would reduce ED utilization compared to standard care. Additionally, the study assessed whether this would enhance plannability of AF related healthcare utilization. Methods: A historically controlled, prospective clinical trial was conducted. The 'intervention' group are patients undergoing PVI for AF, all patients in this group receive a KM device for 1 year for remote rhythm monitoring. The historical control group were patients undergoing PVI between January 2016 and December 2017; these patients did not receive a KM. Data on ED visits, planned and unplanned cardioversions, and outpatient contacts in the year after the PVI were collected for both groups.
- Conditions
- Atrial Fibrillation
- Being tested
- 1-lead ECG
- Keywords
- 1-lead ECG, ED visits
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-lead ECGDevice
patient were handed out a 1 lead ECG device, they were free to use it anyway they wanted, even not at all
| Study group | Role | What they receive |
|---|---|---|
| 1-lead ECG group | Patients after PVI that received a 1-lead ECG Receives: Device: 1-lead ECG | |
| standard care group | standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of ED visits
Measured: 1 year after PVI
Secondary outcomes (1)
ratio of the number of cardioversions emergency vs planned
Measured: 1 year after PVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start30 Sep 2018
- Primary completion30 Sep 2021
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luuk Hopman, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283654
- Sponsor's protocol ID
- VUmc 2018.539
- Acronym
- relievED
- Status last verified
- Apr 2024
- First submitted
- 21 Feb 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Selder JL, Mulder MJ, van de Vijver WR, Croon PM, Wentrup LE, van der Pas SL, Twisk JWR, Tulevski II, Van Rossum AC, Allaart CP. Does providing atrial fibrillation patients, after pulmonary vein isolation, with a 1-lead ECG device relieve the emergency department?-A historically controlled prospective trial. PLOS Digit Health. 2024 Dec 20;3(12):e0000688. doi: 10.1371/journal.pdig.0000688. eCollection 2024 Dec.
PubMed 39705212
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation: a Historically Controlled Prospective Trial
- ClinicalTrials.gov ID
- NCT06283654
- Acronym / sponsor ID
- relievED / VUmc 2018.539
- Conditions
- Atrial Fibrillation
- Keywords
- 1-lead ECG, ED visits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the researchers explored a new approach to manage atrial fibrillation, a disease that affects millions worldwide. The goal was to see if using a simple handheld ECG device for monitoring heart rhythm could help patients avoid unnecessary visits to the emergency department (ED) after undergoing a common procedure known as pulmonary vein isolation (PVI). This procedure is often used to treat AF, but following it patients frequently visit the ED due to concerns about their heart rhythm, which can strain healthcare resources. The researchers proved a group of patients with a 1-lead ECG device , which allowed users to check their heart rhythm at any time. The researchers compared the ED utilization over a year with that of patients who received standard care after PVI. The hope was that by using the 1-lead ECG device, patients could better manage their condition from home and only seek medical help when truly necessary.
Detailed description
Atrial fibrillation (AF) is a prevalent and clinically significant cardiac arrhythmia, with a growing incidence. The primary objectives in AF management are symptom relief, stroke risk reduction, and prevention of tachycardia-induced cardiomyopathy. Two key strategies for rhythm control include antiarrhythmic drug therapy and pulmonary vein isolation (PVI), with PVI being recommended for selected patients. Even though PVI is effective, post procedural health care utilization is high, contributing to emergency department (ED) overcrowding, which is a global healthcare concern. The use of remote rhythm diagnostics, such as a 1-lead ECG device, may mitigate this issue by reducing ED visits and facilitating more plannable AF care. Objective: This study aimed to assess whether providing AF patients with a 1-lead ECG device for 1 year after PVI would reduce ED utilization compared to standard care. Additionally, the study assessed whether this would enhance plannability of AF related healthcare utilization. Methods: A historically controlled, prospective clinical trial was conducted. The 'intervention' group are patients undergoing PVI for AF, all patients in this group receive a KM device for 1 year for remote rhythm monitoring. The historical control group were patients undergoing PVI between January 2016 and December 2017; these patients did not receive a KM. Data on ED visits, planned and unplanned cardioversions, and outpatient contacts in the year after the PVI were collected for both groups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-lead ECG group | – | Device: 1-lead ECGPatients after PVI that received a 1-lead ECG |
| standard care group | – | –standard care group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with all kinds of AF who underwent a PVI
Key inclusion criteria (1 listed)
- AF and PVI
Key exclusion criteria (1 listed)
- <18y
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-lead ECGpatient were handed out a 1 lead ECG device, they were free to use it anyway they wanted, even not at all | Device | 1-lead ECG group |
Primary outcome
number of ED visits
Time frame: 1 year after PVI
1 secondary outcome
ratio of the number of cardioversions emergency vs planned
Time frame: 1 year after PVI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Derived from this study: PubMed 39705212Selder JL, Mulder MJ, van de Vijver WR, Croon PM, Wentrup LE, van der Pas SL, Twisk JWR, Tulevski II, Van Rossum AC, Allaart CP. Does providing atrial fibrillation patients, after pulmonary vein isolation, with a 1-lead ECG device relieve the emergency department?-A historically controlled prospective trial. PLOS Digit Health. 2024 Dec 20;3(12):e0000688. doi: 10.1371/journal.pdig.0000688. eCollection 2024 Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of ED visits (time frame: 1 year after PVI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06283654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.